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August 18, 2016
FDA Safety Communication: Stop using System 83 Plus Automated Endoscope Reprocessors by Custom Ultrasonics, for reprocessing
duodenoscopes
The FDA is notifying healthcare facilities of Custom Ultrasonics' May 6, 2016 URGENT MEDICAL DEVICE RECALL, and advising users to stop
using its System 83 Plus AERs for reprocessing of duodenoscopes.
Based on the Agency’s February 2016 Safety Communication, at this time, facilities should have transitioned to alternative methods of reprocessing
of duodenoscopes. In addition, FDA is revising its February 2016 Safety Communication to communicate that Custom Ultrasonics’ System 83 Plus
AERs remain in service for the reprocessing endoscopes other than duodenoscopes.
Because inadequately reprocessed duodenoscopes have been associated with patient infections and death, healthcare facilities should not use
Custom Ultrasonics’ System 83 Plus AERs for reprocessing duodenoscopes, and should have transitioned to alternative methods of reprocessing
these particular endoscopes.
The FDA will continue to provide updates as new information becomes available.
FDA created a website to provide the public with up-to-date information about AERs for which the Agency has reviewed adequate reprocessing
validation for duodenoscopes.
The FDA advises healthcare facilities to:
Identify and transition to alternate methods to reprocess duodenoscopes, such as manual high-level disinfection, alternative AERs, liquid chemical
sterilization, or other sterilization methods according to the duodenoscope manufacturers’ reprocessing instructions. Regardless of reprocessing
method, hospital staff should manually clean duodenoscopes according to the manufacturer’s instructions.
Before transitioning to an alternative method, be sure that the duodenoscopes your facility uses are compatible with the alternative method by
referring to the duodenoscope manufacturer’s reprocessing instructions and the AER manufacturer’s instructions.
The FDA continues to recommend the following best practices for all flexible endoscopes:
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Always clean endoscopes and their accessories thoroughly before high-level disinfection, liquid chemical sterilization, or other sterilization
methods.
Ensure ready access and promote strict adherence to manufacturer’s instructions for cleaning other flexible endoscopes.
Implement a comprehensive quality control program for reprocessing flexible endoscopes, including:
written procedures for monitoring training and adherence to the program
documentation of equipment, tests, processes, and quality monitors used during the reprocessing procedure.
Ensure that staff responsible for reprocessing endoscopes understand the importance of their role in reprocessing the device and maintain
proficiency in performing required reprocessing tasks.
Adhere to general endoscope reprocessing guidelines and practices established by the infection control community and endoscopy
professionals.
Read the FDA safety alert.
New MRI technique sheds technology's longtime limits
A new technology harnesses imperfections that typically compromise MRI exams to create images resolved enough to enable consistent diagnoses
across populations for the first time. These are findings of a study led by NYU Langone Medical Center and published August 16 in Nature
Communications.
Since its emergence in the 1970s, magnetic resonance imaging (MRI) has given physicians a better look inside tissues, helping to diagnose
maladies from brain tumors to internal bleeding to torn ligaments. Such scans are woven into every part of medicine, with U.S. physicians now
ordering upwards of 28 million per year.
Despite this impact, all MRI scanners have the same problem. During a scan, antennas hit the atoms making up tissues with radio waves that tip
them out of their magnetic equilibrium. Once tipped, the atoms' magnetic forces spin like tops to emit radio signals that reveal their identity and
position, the building blocks of an image. The quality of an image, however, depends on equal exposure of atoms to magnetic fields, which not only
vary scanner to scanner, but also in their interactions with different parts of even a single tissue sample.
Thus, traditional MRI radio waves "light up" some parts of a sample better than others, with imperfections blacking out areas of images. Industry has
invested heavily in magnetic coils that seek to force uniform exposure, but many MR exams today still yield darkened "artifacts."
"The advances outlined in our study eliminate artifacts and create images accurate enough that we can now assign numerical values to anatomical
features," says study author Daniel Sodickson, MD, PhD , professor in the Department of Radiology, member of the Perlmutter Cancer Center at
NYU Langone, and director of the Bernard and Irene Schwartz Center for Biomedical Imaging.
"This marks the advent of 'quantitative MRI,' where new kinds of tissue maps become the gold standard for diagnoses and reveal disease patterns
that are consistent from patient to patient," says Sodickson, also lead investigator for the Center for Advanced Imaging Innovation and Research. "It
will turn scanner design on its head."
The new approach also promises to accomplish superior imaging with less expensive machines, a must in the face of the cost cutting underway in
healthcare, the authors say. Faster, simpler approaches would also solve the problem of scanners that, elaborately equipped to correct for field
variations, require meticulous calibration and lengthen exam time beyond what some patients can tolerate.
Despite decades of massive investment, traditional MRI still yields only qualitative images that are not resolved enough to guide database-driven
diagnoses and research in the age of "big data."
Visit EurekAlert for the study.
AORN responds to ACS statement on attire
The American College of Surgeons (ACS) recently released a statement on operating room attire that has stimulated discussion in the perioperative
nursing community. In response to numerous calls from members and nonmembers, the Association of periOperative Registered Nurses (AORN)
has reviewed the ACS statement in detail to compare all available evidence to the statement and provide perioperative team members with the
information necessary to achieve high quality safe patient care.
Of particular concern to AORN and its membership of 40,000 perioperative registered nurses, is the introductory statement, "The ACS guidelines for
appropriate attire are based on professionalism, common sense, decorum, and the available evidence." Regulatory agencies, accrediting bodies,
and patients expect healthcare organizations to follow guidelines that are evidence-based rather than recommendations based on professionalism,
common sense, or decorum.
All current evidence for safe surgical attire is presented with recommended evidence-based practices in AORN's Guideline for Surgical Attire. The
AORN guideline development process meets the rigorous requirements of, and are accepted by, the AHRQ National Guidelines Clearinghouse.
The AORN evidence review of the ACS statement included some agreement with particular points and disagreement with others. Here are a few of
AORN’s responses:
ACS: Soiled scrubs and/or hats should be changed as soon as feasible and certainly prior to speaking with family members after a surgical
procedure.
AORN: The Occupational Safety and Health Administration (OSHA) requires attire that has been penetrated by blood, body fluids or other infectious
materials be removed immediately or as soon as possible and be replaced with clean attire.
ACS: Scrubs and hats worn during dirty or contaminated cases should be changed prior to subsequent cases even if not visibly soiled.
AORN: Evidence shows that perioperative team members who are following standard precautions, using personal protective equipment (PPE) and
conducting hand hygiene should not need to change scrubs and hats between cases. Doing so could give a false sense of security that PPE and
hand hygiene are not needed. This statement may cause confusion by introducing a different standard for surgeons than for other perioperative team
members. All should be following the same, evidence-based standards.
ACS: Masks should not be worn dangling at any time.
AORN: Evidence-supported.
ACS: Operating room (OR) scrubs should not be worn in the hospital facility outside of the OR area without a clean lab coat or appropriate cover up
over them.
AORN: Evidence shows that lab coats can be contaminated with large numbers of pathogenic organisms. Evidence also shows that lab coats are
not always discarded daily after use or laundered on a frequent basis and therefore, should not be recommended wear over scrubs. If one chooses
to wear a lab coat it should be laundered in a health care accredited laundry facility after each daily use and sooner when contaminated, or should
be single use.
Visit AORN for the complete response to the ACS statement on surgical attire.
Halyard Health and Team Gleason team up for ALS awareness
Halyard Health and Team Gleason announced they are teaming up to raise awareness for amyotrophic lateral sclerosis, commonly known as ALS, a
terminal neuromuscular disease.
Team Gleason, a non-profit organization that provides leading-edge technology, equipment and services to individuals with neuromuscular diseases
or injuries, was founded by former professional football player Steve Gleason and his wife Michel.
Through the alliance, Team Gleason will share Steve’s story of his use of the MIC-KEY Gastrostomy Feeding Tube manufactured by Halyard Health.
The MIC-KEY G-Tube’s low-profile design allows it to sit at skin level, making it an easier-to-conceal, more comfortable option than conventional
feeding tubes.
According to the ALS Association, more than 5,600 people in the U.S. are diagnosed with ALS each year and about 30,000 people have the disease
at any given time. As a person’s condition worsens, they can have difficulty eating because of trouble swallowing, aspiration and choking.
Many patients turn to enteral feeding tubes to help them get the nutrients they need to maintain their weight and energy so they can continue living
productive lives as the disease progresses. Feeding tubes can also be used to administer medication, help increase fluid intake, and to reduce the
risk of chest infections caused by aspiration.
Steve was diagnosed with ALS in 2011. In 2013, after struggling to maintain a healthy weight, his doctor recommended an enteral feeding tube to
help him get the nourishment he needed. The first feeding tube Steve used was cumbersome, with a long tube that could not be easily concealed.
After consulting with others in the ALS community, Steve learned about the MIC-KEY G Feeding Tube.
Steve Gleason has been compensated by Halyard Health.
Visit Halyard for the release.
Ebola. Zika. Could a rapid-response fund help the US address crises faster?
Wouldn’t it be easier to respond to the next public health crisis if the federal government didn’t have to wait for Congress? That’s the lesson that top
lawmakers have learned from the seemingly endless standoff over emergency funds for the Zika virus.
Now, there’s a reasonable chance that the next health spending bill will include a reserve fund that the CDC can use the next time there’s an
infectious disease crisis.
The House version of the bill, which would fund the federal health agencies for the fiscal year that starts in October, has a $300 million “rapid
response reserve fund” for infectious diseases. It’s a smaller version of an idea that Democratic lawmakers and current and former Obama
administration officials have been promoting for months, ever since it became clear that Congress was incapable of anything close to a rapid
response to Zika.
It’s not guaranteed to become law. House Republicans would have to convince their Senate counterparts to accept it, since it’s not in the Senate
version. They’d have to reach a broader agreement on the health spending bill, which is full of other provisions President Obama would likely
consider veto bait.
That said, top House Republicans are optimistic that they can get some version of the fund signed into law. They believe it would establish the
precedent that, having dealt with Zika and Ebola outbreaks in the last three years, federal health officials should always have an emergency fund at
hand so they can respond quickly to the next infectious disease crisis.
CDC director Tom Frieden insists, however, that his agency still needs the emergency Zika funding that Obama asked for six months ago — the one
that is still stuck in Congress, with no sign that either party will budge even after Congress returns in September.
Public health advocates want a larger reserve fund, too. Cynthia Pellegrini, a lobbyist for the March of Dimes who has helped to coordinate the push
for emergency Zika funds, said the $300 million amount is “woefully inadequate” and would require taking money away from other important health
priorities.
Visit STAT News for the story.
Study says FluMist vaccine does indeed work, contradicting CDC
It came as a surprise this June when the CDC recommended against using the nasal flu vaccine for the 2016-2017 flu season, citing a lack of
evidence that it works.
Now, findings from a Canadian study appear at first blush to contradict the research that led the Advisory Committee on Immunization Practices to
recommend against that live attenuated vaccine.
But things aren't so simple. In fact, the conflicting evidence about the live nasal flu vaccine offers an excellent case study on how complex the task of
analyzing flu vaccine data and making recommendations really is.
"Sometimes the public wants a very simple message, and unfortunately life's not like that," Mark Loeb, the new study's lead author and director of
the division of infectious diseases at McMaster University in Ontario, tells Shots.
Loeb's study focused on 52 Hutterite communities in rural Canada, because their relative isolation makes for an environment with fewer confounding
factors. Researchers randomly assigned 1,186 children, ages 3 to 15, to receive either the live attenuated nasal flu vaccine or the inactivated flu
vaccine by injection.
During the three flu seasons from 2012 to 2015, 5.3 percent of the children in the live nasal vaccine group and 5.2 percent of the children in the
inactivated vaccine group had lab-confirmed influenza, revealing that the two vaccines were equally effective.
The study lacked a control group of children who did not get a vaccine, but previous studies showed a flu infection rate of about 10 percent among
unvaccinated children and of 4 to 5 percent in vaccinated children in these communities, Loeb says. Rates of antibiotic prescriptions, ER visits,
respiratory illnesses, hospital admissions and school or work absences were also similar across the two groups.
These findings, published Monday in Annals of Internal Medicine, parallel the early evidence for the live nasal vaccine in the U.S. which led ACIP to
preferentially recommend it for children for the 2014-2015 season. CDC data consistently showed the live nasal vaccine to be very effective in
children until 2013, when the vaccine went from including three strains (trivalent) to including four strains (quadrivalent).
And therein lies the rub: The new Canadian study used the trivalent vaccine, while ACIP analyzed data using the quadrivalent vaccine, and among
U.S. children.
Several phenomena may contribute to the incongruity in the data. Going from the trivalent to the quadrivalent vaccines, for example, could have
introduced more vaccine interference. Each vaccine strain competes to infect enough cells so that the virus can replicate and induce an immune
response in those cells. More strains means more competition among the strains to infect cells, so multistrain flu vaccines include higher doses of
each virus.
But that alone would not explain lower U.S. effectiveness, because the U.K., Finland and Astra Zeneca studies showed higher effectiveness with the
quadrivalent vaccine. Another factor could be that U.S. children have been vaccinated regularly enough since the first universal flu vaccine
recommendation in 2007 that they've built up an underlying immunity.
That underlying immunity could interfere with responses to new doses, progressively lessening the vaccine's apparent effectiveness each year. (This
is more likely with live nasal vaccines than with the shot because they induce different types of immune responses.) Bias in the study or other as-yetunidentified factors could play a role too.
Visit NPR for the article.
Researchers explain why secondary infection with MRSA kills influenza patients
Researchers have discovered that secondary infection with the Methicillin-resistant Staphylococcus aureus (MRSA) bacterium often kills influenza
patients because the flu virus alters the antibacterial response of white blood cells, causing them to damage the patients' lungs instead of destroying
the bacterium.
The study, which will be published online August 15 ahead of issue in The Journal of Experimental Medicine, suggests that inhibiting this response
may help treat patients infected with both the flu virus and MRSA.
Many influenza patients develop severe pneumonia as a result of secondary infections with MRSA. Over half of these patients die, even when
treated with antibiotics that are usually capable of clearing MRSA infections.
Keer Sun, an assistant professor at the University of Nebraska Medical Center, previously discovered that mice infected with influenza are
susceptible to MRSA because the ability of their macrophages and neutrophils to kill bacteria by releasing hydrogen peroxide and other reactive
oxygen species is suppressed. But it remained unclear why MRSA-infected influenza patients often die, even after receiving an appropriate antibiotic
treatment.
Sun and colleagues now reveal that this may be because the patients' white blood cells cause extensive damage to their lungs.
"Our results demonstrate that influenza infection disrupts the delicate balance between Nox2-dependent antibacterial immunity and inflammation,"
says Sun. "This not only leads to increased susceptibility to MRSA infection but also extensive lung damage. Treatment strategies that target both
bacteria and reactive oxygen species may significantly benefit patients with influenza-complicated MRSA pneumonia."
Visit News Medical for the article.
Physicians and medical device reps: Too close for comfort?
Medical device sales representatives may be getting too close to the physicians they sell to and taking on extra roles in the operating room,
according to a new study sponsored by Georgetown University.
Researchers in the study aimed to explore the relationships between surgeons and medical device representatives through group and individual
open-ended interviews with 3 former or current medical device representatives and 19 surgeons.
In the operating room, surgeons reported not being able to operate complex devices without the help of sales technicians, and many technicians also
made ready surgical trays and tools for operating surgeons, according to study authors.
“This is one of the reasons why, currently, you need a rep in the operating room,” a medical device rep surveyed in the study said. “Who’s to say who
else will know when we get to surgery in the morning whether you’re opening the right implants, or whether you’re opening the right trays?…[I]t’s
useful to have somebody else in the room whose specific job is to have that information on hand always.”
While the relationships were cultivated to make the physicians invaluable to the staff, the personal relationships they developed could turn out to be
problematic when it came time to pitch new products, according to the study.
“I often felt like I’m driving up the costs of the healthcare system,” a surveyed medical device rep said. “We used to sell an implant that has 99%
survivorship at 15 years, which is great, right? We were told to not ever market it to anybody. If a doctor asked for it by name, we would give it to
him. We want to market the newer, the better technology. I’m not certain I ever thought the newer technology was better. There certainly wasn’t data
on it. I was uncomfortable with those sorts of things.”
Study authors said that the “issues and potential pitfalls of excessive industry influence in medical care and physicians’ treatment decision making
are at least as urgent for implantable medical devices as they are for pharmaceuticals,” but said that the issues are less studied than their
pharmaceutical counterparts.
“We call upon professional societies, hospital systems, individual hospitals, collaborative private practices, and regulatory bodies to develop realtime, workable methods to systematically collect, analyze, and disseminate data on implant surgeries and their short- and long-term outcomes to the
professions and the public,” study authors concluded.
The study was published early this month in the journal Plos One.
Visit Mass Device for the article.